Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin - LARVOL DELTA

Unveiling the Accurate Site-Specific N- and O-Glycosylation of Hyperglycosylated Erythropoietin Drugs by an Integrated Approach. (PubMed, Anal Chem) - "We applied this strategy to compare the glycosylation profiles of the commercial hyperEPO drug darbepoetin alfa and a novel high-potency analogue, EPO-XL...Collectively, this study presents the first site-specific N- and O- glycosylation profiles of hyperEPO proteins, offering valuable guidance for the quality control and rational design of these therapeutics. The state-of-the-art analytical strategy introduced here holds great potential to advance the site-specific glycosylation characterization of proteins with complex glycosylation."

Journal

Attribute based cross classification analyses from the BRIGHTEN study reveal that therapeutic responsiveness to erythropoiesis stimulating agents predicts cardiorenal prognosis in renal anemia. (PubMed, Sci Rep) - "Darbepoetin alfa doses during 12 weeks were lowest in younger men (0.79 μg/kg) and highest in older women (1.08 μg/kg)...This study revealed that renal outcomes correlated with Hb levels and ESA responsiveness in patients with CKD and anemia, especially in younger men with poor renal outcomes and with ESA resistance in older women with the best renal outcomes. Cross-classification helps identify specific patient attributes that should be targeted for optimizing anemia treatment in CKD."

Journal • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

A Rare Case of Parvovirus Infection Causing Pure Red Cell Aplasia in a Kidney-Pancreas Transplant Recipient. (PubMed, Nephrology (Carlton)) - "He had normal haematinics, with a persistent reticulocytopenia (0.3%, 7 × 109 cells/L) despite 80 μg per week of subcutaneous darbepoetin alfa...High dose intravenous immunoglobulin (IVIG total 400 mg/kg/day over 5 days) and immunosuppression reduction led to haemoglobin stability to > 80 g/L over 14 days. Treatment response was further extrapolated by a parvovirus PCR cycle threshold increase to 25, 7 days after first IVIG dose in the absence of gold standard quantitative PCR testing unavailability."

Journal • Gastroenterology • Hematological Disorders • Infectious Disease • Peptic Ulcer • Transplantation

ANTI-HEMOJUVELIN MONOCLONAL ANTIBODY FURTHER ENHANCES HEMATOLOGIC RESPONSE TO ESA AND/OR LUSPATERCEPT IN MICE (EHA 2025) - P1, P1/2 | "DISC-0974 is currently in clinical studies to treat anemia in patients with MF (NCT05320198) and chronic kidney disease (NCT05745883)...In the DBIO-100/ESA combo study, wild-type C57BL/6J male mice were randomized to receive vehicle, darbepoetin alfa (DPO, an example of ESA; 1 or 3 ug/kg via subcutaneous route), DBIO-100 (20 mg/kg via intravenous route), or a combination of DBIO-100/DPO... These studies confirmed that DPO (an ESA) and DBIO-147 can increase hematological parameters in wild-type mice. Adding DBIO-100, a mouse anti-HJV monoclonal antibody, to either DPO or DBIO-147 led to further hematological improvements in vivo. Moreover, DBIO-100 enhanced serum iron availability for erythropoiesis in wild-type mice."

Preclinical • Anemia • Chronic Kidney Disease • Hematological Disorders • Hematological Malignancies • Myelofibrosis • Nephrology • Oncology • Renal Disease

Darbepoetin Alfa Once Monthly Dosing Schedule Maintains Hemoglobin Concentration Comparable to Every 2 Weeks Dosing Schedule in Advanced Chronic Kidney Disease Patients Not on Dialysis, Multicenter, Phase 4 Study (clinicaltrials.gov) - P4 | N=77 | Active, not recruiting | Sponsor: Gangnam Severance Hospital

New P4 trial • Chronic Kidney Disease • Nephrology • Renal Disease

Deucravacitinib Treatment for Psoriasis Complicated by Myelodysplastic Syndrome Without Exacerbation of the Underlying Hematologic Disorder: A Case Report. (PubMed, Cureus) - "Moreover, his anemia remained well controlled without the need for monthly darbepoetin alfa injections. This case highlights the potential of deucravacitinib as a safe and effective treatment option for psoriasis patients with concurrent MDS. Given the emerging understanding of TYK2 as an oncogenic driver in myeloproliferative diseases, further studies are warranted to clarify the therapeutic implications of TYK2 inhibition in this patient population."

Journal • Cardiovascular • Chronic Kidney Disease • Dermatology • Hematological Disorders • Hematological Malignancies • Immunology • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Nephrology • Oncology • Psoriasis • Renal Disease • TYK2

Integrative Analysis of Drug Co-Prescriptions in Peritoneal Dialysis Reveals Molecular Targets and Novel Strategies for Intervention. (PubMed, J Clin Med) - " We found commonly prescribed drugs such as furosemide, sucroferric oxyhydroxide, calcitriol, darbepoetin alfa, and aluminum hydroxide to be integral components of PD patient management, prescribed in over 30% of PD patients. The molecular-network-based approach found combinations of drugs like theophylline, fluoxetine, celecoxib, and amitriptyline to possibly have synergistic effects and to target dysregulated molecules of PD-related pathomechanisms. Two further distinct categories of drugs emerged as particularly interesting in our study: selective serotonin reuptake inhibitors (SSRIs), which were found to modulate molecules implicated in peritoneal fibrosis, and vascular endothelial growth factor (VEGF) inhibitors, which exhibit anti-fibrotic properties that are potentially useful for PD. This comprehensive exploration of drug co-prescriptions in the context of PD-related pathomechanisms provides valuable insights for opening future therapeutic strategies and..."

Journal • Fibrosis • Immunology • Renal Disease

A Win-Ratio Analysis of the Cardiovascular Safety of Vadadustat in Patients With CKD-Related Anemia Undergoing Dialysis (ERA 2025) - "Vadadustat was noninferior to darbepoetin alfa in a win-ratio analysis of cardiovascular safety among patients with dialysis-dependent CKD in the global INNO 2VATE trials. Results from this win-ratio analysis were consistent with the results from the original time-to-first event analysis of the INNO 2VATE trials."

Clinical • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Myocardial Infarction • Nephrology

Consideration of the amount of serum ferritin required to increase hemoglobin (ERA 2025) - "Hb levels were managed with darbepoetin alfa (DA), a long-acting ESA, to maintain a target range of 10–12 g/dL according to Japanese guidelines... This study showed that serum ferritin decreased by approximately 40 ng/dL for every 1 g/dL increase in Hb. Changes in serum ferritin were strongly dependent on RBC count but not on MCH. As an indicator of iron deficiency in HD patients, the Japanese guidelines suggest a ferritin level of less than 50 ng/mL, which is similar to our study."

Anemia • Chronic Kidney Disease • Diabetic Nephropathy • Hematological Disorders • Nephrology • Renal Disease

Erythropoiesis-Stimulating Agent Hyporesponsiveness and Malignancy Development in non-Dialysis-Dependent CKD Patients: A Prospective Cohort Study (ERA 2025) - "Initial ESA responsiveness was assessed using the erythropoietin resistance index (ERI-1B), calculated as the ratio of darbepoetin-alfa dose (μg) to hemoglobin concentration (g/dL) at 12 weeks after darbepoetin alfa initiation... This study demonstrated that both initial ESA hyporesponsiveness and subsequent declines in responsiveness were significantly associated with the development of malignancy in patients with non-dialysis-dependent CKD. Monitoring ESA responsiveness could provide valuable insights for identifying patients at potential risk for malignancy."

Clinical • Anemia • Chronic Kidney Disease • Colorectal Cancer • Nephrology • Oncology • Solid Tumor

Body Composition as a Determinant of Erythropoietin Resistance in Hemodialysis Patients: Insights from a Serbian Single Center Cohort Study (ERA 2025) - "Among the cohort, 63.3% were treated with short-acting ESA, and 36.7% received darbepoetin alfa... Higher adiposity, as indicated by BMI, FTI, and rel FAT, is associated with reduced erythropoietin resistance. While no significant differences were observed between ESA types, these findings highlight the potential role of body composition in guiding personalized anemia management strategies for hemodialysis patients."

Clinical • Anemia • Hematological Disorders • Nephrology • Obesity • Renal Disease

Impact of venous thromboembolism on survival in multiple myeloma patients receiving bispecific antibody therapy: Insights from real-world data. (ASCO 2025) - "However, there is limited information regarding the rates of VTE and survival outcomes with FDA-approved bispecific antibodies (BsAbs) such as teclistamab, elranatamab, and talquetamab...After propensity score matching for covariates [accounting for age, sex, ECOG, BMI, COVID-19, pneumonia types, certain infectious diseases, hypertensive diseases, surgery, and medications (dexamethasone, epoetin alfa, darbepoetin alfa)] although RR lost statistical significance (RR 1.333, 95% CI 0.888-2.001), the MM patients with VTE still had statistically significantly shorter overall survival and higher risk of death (50.07% vs. 72.27% survival probability at 18 months, log-rank test p=0.007; HR 1.989, 95% CI 1.190-3.325). RWD demonstrated that MM patients treated with BsAbs who developed VTE had a higher risk of death and shorter overall survival. Further analysis, possibly evaluating patient-level data on a larger cohort of patients with more sophisticated confounding controls, is..."

Clinical • Real-world • Real-world evidence • Cardiovascular • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Multiple Myeloma • Oncology • Pneumonia • Respiratory Diseases • Venous Thromboembolism

Mean Corpuscular Volume Is Not a Reliable Predictor of Iron Deficiency in Patients With Chronic Kidney Disease: A Post-Hoc Analysis of the BRIGHTEN Trial. (PubMed, Cureus) - "Methods This retrospective cohort study included adult patients with ND-CKD from the BRIGHTEN (oBservational clinical Research In chronic kidney disease patients with renal anemia: renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis-stimulating agents, darbepoetiN alfa) trial (enrolled from June 2014 to September 2016) in Japan who were started on darbepoetin-alpha for renal anemia and patients who were not started on iron supplementation during weeks 0-24...Conclusion Neither MCV nor the changes in MCV could reliably diagnose iron deficiency in patients with ND-CKD. Ferritin level < 130 ng/mL could predict new-onset iron deficiency within 12 weeks."

Journal • Retrospective data • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs) (clinicaltrials.gov) - P3 | N=319 | Completed | Sponsor: Akebia Therapeutics | Phase classification: P3b ➔ P3

Phase classification • Anemia • Hematological Disorders

Safety and Efficacy of Vadadustat for the Treatment of CKD-Related Anemia within and outside the United States. (PubMed, J Am Soc Nephrol) - "In patients with DD-CKD, safety (vis-à-vis MACE) and efficacy (vis-à-vis change in hemoglobin) of vadadustat and darbepoetin alfa were similar when stratified by region (US versus non-US). In US patients with NDD-CKD, safety and efficacy of vadadustat and darbepoetin alfa were similar."

Journal • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Myocardial Infarction

Comparative efficacy of epoetin alfa vs. darbepoetin in children with chronic kidney disease: a systematic review, meta-analysis and cost-effectiveness analysis. (PubMed, J Nephrol) - "rHuEPO is the most cost-effective initial anemia treatment in pediatric CKD. However, transitioning to DA may be considered for patients who do not achieve adequate Hb response. The small number of randomized controlled trials (RCTs), variability in dose conversion, and study heterogeneity may limit generalizability."

HEOR • Journal • Retrospective data • Review • Chronic Kidney Disease • Hematological Disorders • Nephrology • Pediatrics • Renal Disease

Vascular Access Thrombosis Events in Patients With Dialysis-Dependent CKD Treated With Vadadustat or Darbepoetin Alfa: The INNO2VATE Trial Program. (PubMed, Kidney Med) - P3 | "In this secondary analysis of the INNO2VATE program in patients with DD-CKD and CKD-related anemia receiving hemodialysis, first VAT rates were numerically higher among patients treated with vadadustat versus darbepoetin alfa but statistically not different. The rates of first and recurrent VAT events were similar between treatment groups."

Clinical • Journal • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease • Thrombosis

Darbepoetin alfa use in trauma and acute care surgery patients who abstain from blood products: A case series and discussion. (PubMed, Am J Health Syst Pharm) - "The use of darbepoetin alfa appeared to be a therapeutic option to treat anemia in trauma and acute care surgery patients who abstain from blood products. Future studies are needed to compare epoetin alfa and darbepoetin alfa."

Journal • Cardiovascular • Hematological Disorders • Myocardial Infarction

Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA (clinicaltrials.gov) - P1/2 | N=13 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | N=41 ➔ 13

Enrollment change • Enrollment closed • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Mechanical Support Escalation to Bridge Anemic Jehovah's Witness to Cardiac Transplantation (ISHLT 2025) - "He was upgraded to Impella 5.5® (Abiomed, Danvers, MA) and treated with intravenous iron and Darbepoetin Alfa with subcutaneous heparin. Prior case reports have elaborated on the selective use of erythropoiesis stimulation in tMCS. To our knowledge, this is the first case report that describes efficacy of this strategy in a patient with decompensation and blood loss anemia requiring tMCS escalation as bridge to OHT."

Anemia • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Thrombosis • Transplantation

Protocol for Comparing Hemoglobin Control between Darbepoetin Alfa and Short-acting rHuEPO in Maintenance Hemodialysis Patients (ChiCTR) - P4 | N=410 | Not yet recruiting | Sponsor: Shenzhen Second People's hospital; Shenzhen Second People's hospital

New P4 trial • Anemia • Hematological Disorders • Renal Disease

Cardiovascular Risk in Patients With DD-CKD Randomized to Vadadustat vs Darbepoetin Alfa With or Without Cardiovascular Disease (NKF-SCM 2025) - "In patients with a history of CV disease, the hazard ratio (HR) for MACE was 0.95 (95% CI: 0.80, 1.13) and for patients without a history of CV disease, HR for MACE was 1.00 (95% CI: 0.77, 1.30). Secondary safety outcomes were similar ( Figure ).Conclusion CV risk with VADA was similar to DA irrespective of baseline CV disease history."

Clinical • Anemia • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Hematological Disorders • Myocardial Infarction

Vadadustat for Treatment of Anemia in Older vs Younger Patients With Dialysis-Dependent-CKD (NKF-SCM 2025) - "In ph3 trials of patients with DD-CKD (INNO 2 VATE), VADA was noninferior to darbepoetin alfa (DA) in time to first major adverse cardiovascular event (MACE: a composite of all-cause mortality, nonfatal MI, and nonfatal stroke) and hemoglobin (Hb) correction/maintenance. NI for both primary safety (MACE) and efficacy was met in each of the 2 age strata. In patients <65y, incidence of TEAEs was 87% vs 88%, and ≥65y it was 89% vs 91% in VADA vs DA, respectively.Conclusion In post hoc analyses, safety and efficacy of VADA were noninferior to DA irrespective of age stratum."

Clinical • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders

Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment of Anemia in CKD Patients on Dialysis (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company | Active, not recruiting ➔ Completed

Trial completion • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD) (clinicaltrials.gov) - P3 | N=214 | Completed | Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company | Active, not recruiting ➔ Completed

Trial completion • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease